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ARS Pharmaceuticals Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on neffy® for the Treatment of Type I Allergic Reactions Including Anaphylaxis
SAN DIEGO, May 09, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"SAN DIEGO, May 09, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the Pulmonology, Allergy-Drugs Advisory Committee (PADAC) meeting to review the new drug application (NDA) for neffy®. neffy has the potential to be the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions (type 1), including anaphylaxis. The advisory committee meeting is scheduled to begin at 9:00 AM ET on May 11, 2023. Briefing materials, including FDA’s addendum to the documents, and webcast information for the meeting can be accessed at https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-11-2023-pulmonary-allergy-drugs-advisory-committee-meeting-announcement-05112023#event-materials. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA. “We are confident in the robust data package with neffy and believe our submission contains the information FDA indicated would be appropriate to support a potential approval of the first-ever non-injectable epinephrine spray,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer at ARS Pharma. “We look forward to discussing this information with the PADAC members and presenting the details of our clinical findings across multiple registrational studies later this week.” ARS’s NDA submission was based on data from four primary registrational studies showing that 2.0 mg intranasal dose of neffy met all clinical endpoints recommended by FDA and that its pharmacokinetics were within the range of approved epinephrine injection products. These data included studies in adults, with self-administration and caregiver administration, as well as in children with Type I allergies ≥30 kg (66 lbs). In addition, neffy has been well-tolerated to date with more than 600 individuals in clinical trials receiving at least one dose, and many with repeat administration. Adverse events in neffy clinical trials were generally mild in nature without any meaningful nasal irritation or pain, and...